Secretary's Advisory Committee on Genetics, Health, and Society, 14577-14578 [07-1532]

Download as PDF Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices clerical hours. [(1,321,155 × 10 minutes)/60 minutes = 220,193 hours] sroberts on PROD1PC70 with NOTICES Instructions to Consumers The Rule also requires that certain instructions be provided to consumers. See Rule sections 610.2(b)(2)(iv)(A, B), 610.3(a)(2)(iii)(A, B). Minimal associated time or cost is involved, however. Internet instructions to consumers are embedded in the centralized source Web site and do not require additional time or cost for the nationwide consumer reporting agencies. Similarly, regarding telephone requests, the automated phone systems provide the requisite instructions when consumers select certain options. Some consumers who request their credit reports by mail may additionally request printed instructions from the nationwide and nationwide specialty consumer reporting agencies. Staff estimates that there will be a total of 1,588,055 requests each year for free annual file disclosures by mail.11 Based on their knowledge of the industry, staff estimates that of the predicted 1,588,055 mail requests 10% (or 158,806) will request instructions by mail. If printed instructions are sent to each of these consumers by mail, requiring 10 minutes of clerical time per consumer, this will total 26,468 hours. [(158,806 instructions × 10 minutes)/60 minutes per hour] Labor costs: $5.19 million. Labor costs are derived by applying hourly cost figures to the burden hours described above. Accordingly, staff estimates that it will cost $70,195 to provide annual file disclosures for requests that require a telephone service representative (5,338 hours × $13.15 per hour).12 The remaining processing of requests for annual file disclosures and instructions will be performed by clerical personnel, which will require 291,144 hours at a cost of $4,390,452. [(44,483 hours for handling initial mail request + 220,193 hours for handling requests redirected to mail + 26,468 hours for handling instructions mailed to consumers) × $15.08 per hour 13] As elaborated on above, staff estimates that a total of 14,560 labor hours (8,320 internet contract hours + 6,240 11 This figure includes both the estimated 1% of 26.69 million requests that will be made by mail each year (266,900), and the estimated 5% of the requests initially made over the internet or telephone that will be redirected to the mail process (5% of 99% of 26.69 million = 1,321,155). 12 The 2005 BLS wage rate for telephone operators, $12.36, increased by 6.426% for compounded wage inflation, is $13.15. 13 The 2005 BLS wage rate for employees in administrative support, clerical (level 4 of 9), $14.17, multiplied by 6.426% for compounded wage inflation, is $15.08. VerDate Aug<31>2005 17:09 Mar 27, 2007 Jkt 211001 telephone capacity contract hours) will be needed to obtain, maintain, and adjust the new capacity requirements for the automated telephone call center and the internet web services. This will result in approximately $726,523 per year in labor costs. [(8,320 hours × $51.12 per hour for automated phone service) + (6,240 hours × $48.27 per hour for Web services) 14] Thus, staff estimates that all non-contract labor will cost $5.19 million each year. Capital/other non-labor costs: $8.39 million. Staff believes it is likely that the consumer reporting agencies will use third-party contractors (instead of their own employees) to increase the capacity of their systems. Because of the way these contracts are typically established, these costs will likely be incurred on a continuing basis, and will be calculated based on the number of requests handled by the systems. Staff estimates that the total annual amount to be paid for services delivered under these contracts is $8.39 million.15 Thus, combined, estimated annual labor and non-labor costs are approximately $13.58 million per year.16 William Blumenthal, General Counsel. [FR Doc. E7–5677 Filed 3–27–07; 8:45 am] BILLING CODE 6750–01–P 14 The 2005 BLS wage rate for top-level computer programmers, $48.03, multiplied by 6.426% for compounded wage inflation, is $51.12. The 2005 BLS wage rate for marketing managers, averaged overall, is $45.36; compounded for wage inflation at 6.426% it becomes $48.27. 15 This consists of an estimated $7.69 million for automated telephone cost ($1.20 per request × 6.41 million requests) and an estimated $700,000 ($0.035 per request × 20 million requests) for internet web service cost. Per unit cost estimates are based on staff’s knowledge of the industry. 16 The consumer reporting industry is a multibillion dollar market. As of 2002, it is estimated to have more than $4 billion dollars in sales of file disclosures. One study indicates that the nationwide consumer reporting agencies had approximately $1.2 billion in earnings in 2002. See Michael Turner, Daniel Balis, Joseph Duncan, and Robin Varghese, ‘‘Free Consumer Credit Reports: At What Cost? The Economic Impact of a Free Credit Report Law to the National Credit Reporting Infrastructure,’’ Washington, DC: Information Policy Institute, September, 2003. Thus, the total labor and non-labor cost burden estimate of $13.57 million represents a small percentage—approximately 1% of the overall market ($13.57 million divided by $1.2 billion). This comparison is conservative, as it does not include the earnings of the nationwide specialty consumer reporting agencies. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 14577 DEPARTMENT OF HEALTH AND HUMAN SERVICES Secretary’s Advisory Committee on Genetics, Health, and Society Office of the Secretary, HHS. The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report to the Secretary of Health and Human Services (HHS) on pharmacogenomics. A copy of the draft report is available electronically at https:// www4.od.nih.gov/oba/sacghs/ public_comments.htm. A copy also may be obtained by e-mailing Ms. Suzanne Goodwin at goodwins@od.nih.gov or calling 301–496–9838. DATES: In order for public comments to be considered by SACGHS in finalizing its report to the Secretary, comments should be submitted by June 1, 2007. ADDRESSES: Public comments on the draft report should be addressed to Reed V. Tuckson, MD, SACGHS Chair, and transmitted via an e-mail to Ms. Goodwin at goodwins@od.nih.gov. Comments also may be mailed to SACGHS, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or faxed to 301– 496–9839. FOR FURTHER INFORMATION CONTACT: Suzanne Goodwin, NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301–496–9838, goodwins@od.nih.gov. SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) established SACGHS to explore, analyze, and deliberate on the broad range of policy needs associated with the scientific, clinical, public health, ethical, economic, legal, and social issues raised by the development, use, and potential misuse of genetic and genomic technologies and make recommendations to the Secretary of HHS and other entities as appropriate. More information about the Committee is available at https://www4.od.nih.gov/ oba/sacghs.htm. One area currently being explored by SACGHS is pharmacogenomics. SACGHS identified the emerging field of pharmacogenomics as a high study priority because it holds significant promise for improving the productivity of the drug development pipeline, increasing the safety and effectiveness of drugs by reducing adverse reactions, and ultimately resulting in a more efficient use of drugs. The draft report describes these opportunities while also AGENCY: SUMMARY: E:\FR\FM\28MRN1.SGM 28MRN1 14578 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices identifying the challenges associated with pharmacogenomics product development and integration into clinical and public health practice. It presents information and recommendations in three major areas: (1) Issues associated with research and development; (2) ‘‘gatekeepers,’’ i.e., those who have major roles in directing the course of pharmacogenomic technologies; and (3) implementation of pharmacogenomics to improve outcomes in clinical practice. SACGHS is requesting comments on all aspects of the draft report and recommendations. In particular, the Committee would welcome feedback on the following questions: • Are the discussions of topics and issues accurate and complete? • Have any significant opportunities, challenges, or other issues been missed? • Does the report adequately describe the range of perspectives on the issues discussed in the report? • Are the draft recommendations specific enough? • Are there other strategies for addressing the issues? • Which draft recommendations should be of highest priority for the Federal Government to address? • Appendix A of the report identifies major pharmacogenomics activities in the public and private sector. Are there other relevant initiatives that should be included in the list? Comments received by June 1, 2007, will be considered by SACGHS in preparing the final report. The draft report and the public comments will be discussed at a future SACGHS meeting. Comments also will available for public inspection at the Office of Biotechnology Activities, Monday through Friday, between the hours of 9 a.m. and 5 p.m. Dated: March 22, 2007. Elias A. Zerhouni, Director, National Institutes of Health. [FR Doc. 07–1532 Filed 3–26–07; 9:37 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention sroberts on PROD1PC70 with NOTICES Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated VerDate Aug<31>2005 17:09 Mar 27, 2007 Jkt 211001 October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 72 FR 4514, dated January 31, 2007) is amended to reflect the Order of Succession for the Centers for Disease Control and Prevention. Section C–C, Order of Succession: Delete in its entirety Section C–C, Order of Succession, and insert the following: During the absence or disability of the Director, Centers for Disease Control and Prevention (CDC), or in the event of a vacancy in that office, the first official listed below who is available shall act as Director, except that during a planned period of absence, the Director may specify a different order of succession: 1. Chief Operating Officer, CDC. 2. Director, Coordinating Center for Infectious Diseases. 3. Director, Coordinating Center for Environmental Health and Injury Prevention. 4. Director, Office of Workforce and Career Development. Dated: March 16, 2007. William H. Gimson, Chief Operating Officer, Centers for Disease Control and Prevention (CDC). [FR Doc. 07–1486 Filed 3–27–07; 8:45 am] BILLING CODE 4160–18–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Public Comment on the Proposed Adoption of ANA Program Policies and Procedures; Correction Administration for Native Americans (ANA) ACTION: Notice. AGENCY: SUMMARY: Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b–1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation), Improving the Well-Being of Children—Native American Healthy Marriage Initiative (hereinafter referred to as Healthy Marriage) programs and any Special Initiatives. Under the PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. This Notice also provides additional information about ANA’s plan for administering the programs. On July 18, 2005, ANA published a Notice of Public Comment (NOPC) in the Federal Register (Vol. 70, No. 136) announcing an administrative policy change on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. This change only affected the Healthy Marriage program. On November 21, 2006, ANA published the annual NOPC in the Federal Register (Vol. 71, No. 224), which did not include a necessary correction to the revised administrative policy published on July 18, 2005. On December 22, 2006, ANA published a third Federal Register notice (Vol. 71, No. 246) to clarify the revised administrative policy published on July 18, 2005, on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. ANA received three responses to the December 22, 2006, NOPC clarification. After review and consideration of the comments received, ANA determined that the administrative policy originally published on July 18, 2005, required clarification and revision. This Notice clarifies the agency’s intent and provides a definitive statement on the number of awards an eligible applicant can receive under the Catalog of Federal Domestic Assistance number 93.612. FOR FURTHER INFORMATION CONTACT: Sheila K. Cooper, Director of Program Operations, toll-free at (877) 922–9262. Additional Information: The following statement corrects previous notices: VI. ANA Administrative Policy Change In the July 18, 2005, Federal Register (Vol. 70, No. 136), ANA made an administrative policy change that eligible applicants applying for funding under ANA’s healthy marriage special initiative under Catalog of Federal Domestic Assistance number 93.612, would not be held to the long-standing ANA policy: ‘‘An applicant can have only one active Social and Economic Development Strategies (SEDS) grant operating at any given time.’’ On December 22, 2006, ANA published notice that ANA was clarifying its policy pertaining to E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Notices]
[Pages 14577-14578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Genetics, Health, and Society

AGENCY: Office of the Secretary, HHS.

SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and 
Society (SACGHS) is requesting public comment on a draft report to the 
Secretary of Health and Human Services (HHS) on pharmacogenomics. A 
copy of the draft report is available electronically at https://
www4.od.nih.gov/oba/sacghs/public_comments.htm. A copy also may be 
obtained by e-mailing Ms. Suzanne Goodwin at goodwins@od.nih.gov or 
calling 301-496-9838.

DATES: In order for public comments to be considered by SACGHS in 
finalizing its report to the Secretary, comments should be submitted by 
June 1, 2007.

ADDRESSES: Public comments on the draft report should be addressed to 
Reed V. Tuckson, MD, SACGHS Chair, and transmitted via an e-mail to Ms. 
Goodwin at goodwins@od.nih.gov. Comments also may be mailed to SACGHS, 
Office of Biotechnology Activities, National Institutes of Health, 6705 
Rockledge Drive, Suite 750, Bethesda, MD 20892, or faxed to 301-496-
9839.

FOR FURTHER INFORMATION CONTACT: Suzanne Goodwin, NIH Office of 
Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 
20892, 301-496-9838, goodwins@od.nih.gov.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) established SACGHS to explore, analyze, and deliberate on the 
broad range of policy needs associated with the scientific, clinical, 
public health, ethical, economic, legal, and social issues raised by 
the development, use, and potential misuse of genetic and genomic 
technologies and make recommendations to the Secretary of HHS and other 
entities as appropriate. More information about the Committee is 
available at https://www4.od.nih.gov/oba/sacghs.htm.
    One area currently being explored by SACGHS is pharmacogenomics. 
SACGHS identified the emerging field of pharmacogenomics as a high 
study priority because it holds significant promise for improving the 
productivity of the drug development pipeline, increasing the safety 
and effectiveness of drugs by reducing adverse reactions, and 
ultimately resulting in a more efficient use of drugs. The draft report 
describes these opportunities while also

[[Page 14578]]

identifying the challenges associated with pharmacogenomics product 
development and integration into clinical and public health practice. 
It presents information and recommendations in three major areas: (1) 
Issues associated with research and development; (2) ``gatekeepers,'' 
i.e., those who have major roles in directing the course of 
pharmacogenomic technologies; and (3) implementation of 
pharmacogenomics to improve outcomes in clinical practice.
    SACGHS is requesting comments on all aspects of the draft report 
and recommendations. In particular, the Committee would welcome 
feedback on the following questions:
     Are the discussions of topics and issues accurate and 
complete?
     Have any significant opportunities, challenges, or other 
issues been missed?
     Does the report adequately describe the range of 
perspectives on the issues discussed in the report?
     Are the draft recommendations specific enough?
     Are there other strategies for addressing the issues?
     Which draft recommendations should be of highest priority 
for the Federal Government to address?
     Appendix A of the report identifies major pharmacogenomics 
activities in the public and private sector. Are there other relevant 
initiatives that should be included in the list?
    Comments received by June 1, 2007, will be considered by SACGHS in 
preparing the final report. The draft report and the public comments 
will be discussed at a future SACGHS meeting.
    Comments also will available for public inspection at the Office of 
Biotechnology Activities, Monday through Friday, between the hours of 9 
a.m. and 5 p.m.

    Dated: March 22, 2007.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 07-1532 Filed 3-26-07; 9:37 am]
BILLING CODE 4140-01-P
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